Home NDC 35916-0185 Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
Product NDC 35916-0185
11-digit product format 359160185
Labeler code 35916
Product ID 35916-0185_50036e03-a441-a430-e063-6394a90a72c7
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Private Limited
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-17
Substance ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 6.25; 10 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V9BI9B5YI2 Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1426334 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35916-0185-2 Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 3000 in 1 POUCH CAPSULE, LIQUID FILLED 3000 5 35916-0185-3 Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 2000 in 1 POUCH CAPSULE, LIQUID FILLED 2000 5 35916-0185-3 Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5 35916-0185-4 Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 2 in 1 BOX CAPSULE, LIQUID FILLED 2 5 35916-0185-4 Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 1500 in 1 BAG CAPSULE, LIQUID FILLED 1500 5
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35916-0185-2 35916018502 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0185-2) 2025-05-17 No No Current 35916-0185-3 35916018503 2 POUCH in 1 BOX (35916-0185-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 2 pouch 2025-09-25 No No Current 35916-0185-4 35916018504 2 BAG in 1 BOX (35916-0185-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG 2 bag 2026-01-16 No No Current